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FDA Tentatively Concludes Partially Hydrogenated Oils Are No Longer Generally Recognized as Safe – WHY NOW?

By Bruce Silverglade*

Consumption of trans fatty acids in the United States has decreased sharply in recent years due to efforts by the food industry to reformulate foods and replace partially hydrogenated oils (PHOs) with other ingredients.  According to FDA, intake of trans fat from PHOs decreased more than 75 percent, from 4.6 grams per day in 2003 to 1 gram per day in 2012.  So why has the agency decided to invoke its regulatory authority now?

There may be at least two reasons.  One is buried in the agency’s Federal Register notice, tentatively concluding that PHOs are no longer Generally Recognized as Safe (GRAS).  Another was provided by FDA’s Deputy Commissioner Michael Taylor during the question and answer period at the agency’s press conference on November 7.  Taken together, they provide insight into the agency’s reasons for taking regulatory action despite the progress that has been made.

In its Federal Register notice, FDA states that while trans fat consumption has “decreased significantly,” . . .  “a number of foods with PHOs remain on the market,” 78 Fed. Reg. 67169, 67171-72.  The agency notes that these products fall into one of two categories: foods for which lower trans fat alternatives are currently available (e.g. cookies, baked goods, microwave popcorn,  frozen pies, shortening); and foods for which only limited or no lower trans fat alternatives are available (e.g. ready-to-use frosting, stick margarine), 78 Fed. Reg. 67172.

With regard to the first category of foods identified by the agency, Mr. Taylor, in response to a question from the news media, added that “within these food categories, some companies have reformulated so we know it is technically feasible.”  FDA seems to be saying that, while the industry has made substantial progress overall, PHOs remain common in particular food product categories where at least some companies have found alternatives.  The agency’s thinking seems to be if some companies can reformulate cookies, cakes, and microwave popcorn, than other producers of those products should do so as well.

With regard to margarine, a product listed in the second category of foods identified by the agency, FDA’s action is likely to have only minimal effect because the margarine industry has largely abandoned use of PHOs.  While PHOs are still used in some stick margarines, the margarine category is today dominated by soft tub margarines and spreads that contain little or no trans fat.

Another reason why FDA acted, even though huge progress has already been made, is that the agency believes “individuals with certain dietary habits may still consume high levels of trans fats,” primarily through consumption of food products containing PHOs and that these consumption patterns pose a significant public health problem, 78 Fed. Reg. 67172.  FDA estimates that if PHOs were completely eliminated from the food supply (a step that the agency estimates would cost $8 billion), three to seven thousand deaths from coronary heart disease could be avoided annually creating over $100 billion in benefits, 78 Fed. Reg. 67169, 67173-74.

In brief, FDA is pleased with the overall progress that the food industry has made, but wants companies within particular food categories to follow what the agency regards as best practices to protect particular segments of the population who still consume higher than average amounts of trans fats.

There are several other noteworthy aspects of the agency’s tentative conclusion that PHOs are no longer GRAS:

  • FDA basically states that action on PHOs is not a matter of “if” but rather a matter of “when” and “how.”  However, the agency expressly acknowledges that in certain food categories, there are presently no available or very limited alternatives to PHOs.  The agency, therefore, asks for comment about whether there are “data to support other possible approaches to addressing the use of PHOs in food, such as by setting a specification for trans fat levels . . .”
  • On this point, the Center for Science in the Public Interest (CSPI), which has been pressuring FDA to regulate trans fats for 20 years (and has a close relationship with the agency under the Obama Administration), stated in a news release that FDA’s tentative conclusion “paves the way for the eventual elimination of, or, at the very least, strict curbson the use of artificial trans fat in food.  (Emphasis added.)  Thus, CSPI leaves open the possibility that some uses of PHOs might still be permitted at specified levels, an approach broached by FDA in the agency’s request for comments.
  • Even if the FDA officially concludes that PHOs are not GRAS, the law provides for companies to petition FDA to approve the use of PHOs as a “food additive.”  However, the food additive law requires a showing of a “reasonable certainty of no harm” (emphasis added), and Deputy Commissioner Taylor stated at FDA’s press conference that petitioners would face a “heavy burden” of demonstrating no harm considering that the Institute of Medicine (IOM) has said there is no safe level of intake for trans fat.
  • However, final action on the agency’s tentative conclusion may be years away.  The agency’s 60 day comment period stands a chance of being extended, especially because the agency is under no statutory deadline to act.  FDA often takes at least 12-24 months to finalize a determination.  Even then, the agency establishes a compliance date, which may be 6-12 months or more after the determination is finalized.
  • This is the first time the agency has tentatively concluded that an ingredient (PHOs) that is the principal source of a nutrient in the diet (trans fat) is no longer GRAS.  Will FDA next reconsider the GRAS status of sodium chloride (a/k/a “salt”), the principal source of dietary sodium?  Will such actions invite legal challenges?

Companies concerned with FDA’s tentative conclusion that PHOs are no longer GRAS should utilize the 60 day comment period ending on January 7, 2014, to respond to the agency’s request for information.  A complete list of topics suggested by the agency for comment can be found in the agency’s Federal Register announcement, 78 Fed. Reg. 67174.

An important consideration in submitting comments is the protection of confidential information.  FDA promises that comments containing trade secrets and/or confidential commercial information, which are marked “Confidential,” are exempt from public disclosure under the Freedom of Information Act (5 U.S.C. 552).  However, we advise that additional steps be taken to ensure the protection of such information, as regulatory agencies have been known to release documents marked “confidential” in redacted form that may reveal more than the submitter wishes to make public.

We believe that the following matters may be of particular importance to the agency.

FDA asks:

  • “Can a limit for trans fat content of a particular food sufficiently protect the public health?”  Arguments to allow a limited amount of artificial trans fat in a particular type of food may be persuasive when no substitute ingredient yet exists to permit reformulation of that food.  In situations where substitutes needed for reformulation are non-existent or extremely limited, the agency may be open to setting an interim limit for trans fat, and then decreasing that limit over time as options for reformulation become more readily available.
  • “How long will it take producers to reformulate food products?”  FDA will consider such information in determining when to finalize its tentative conclusion, and when to set a mandatory compliance date once its tentative conclusion becomes final.  Companies with products containing relatively small amounts of trans fats (e.g. products that contain less than 0.5 grams of trans fat per serving, which FDA currently permits to be declared as “0” on the Nutrition Facts panel) may wish to suggest that the agency set priorities, and phase in the GRAS revocation by first starting with products that contain relatively larger amounts of trans fats.
  • “Do small businesses need additional time to reformulate?”  FDA wants to hear.  Small businesses should respond.

FDA remains concerned about the continued use of trans fats and related public health considerations.  FDA’s announcement of its “tentative conclusion” certainly  “ups the ante,” and  places more pressure on companies to remove trans fats from food products.  At the end of the day, however, FDA may be willing to work with industry to avoid unnecessary marketplace disruptions, and seek reasonable solutions that help achieve the agency’s objectives.

* The use of partially hydrogenated oils, the primary source of trans fatty acids in the diet, has been controversial among the general public since 1994, when CSPI petitioned the FDA to list trans fats on the “Nutrition Facts” label.  FDA finalized such a requirement in 2003.  CSPI then petitioned FDA to revoke the GRAS status of PHOs in 2004.  Mr. Silverglade served as CSPI’s director of legal affairs during that period, resigning in 2010.

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